(1) "Ambulatory health care facility" includes any facility
defined in section one, article five-b, chapter sixteen of this
code, that also has a pharmacy, offers pharmacist care, or is
otherwise engaged in the practice of pharmacist care.

(2) "Active Ingredients" means chemicals, substances, or other
components of articles intended for use in the diagnosis, cure,
mitigation, treatment, or prevention of diseases in humans or
animals or for use as nutritional supplements.

(3) "Administer" means the direct application of a drug to the
body of a patient or research subject by injection, inhalation,
ingestion or any other means.

(4) "Board" means the West Virginia Board of Pharmacy.

(5) "Board authorization" means a license, registration or
permit issued under this article.

(6) "Chain Pharmacy Warehouse" means a permanent physical
location for drugs and/or devices that acts as a central warehouse
and performs intracompany sales and transfers of prescription drugs
or devices to chain pharmacies, which are members of the same
affiliated group, under common ownership and control.

(7) "Charitable clinic pharmacy" means a clinic or facility
organized as a not-for-profit corporation that has a pharmacy,
offers pharmacist care, or is otherwise engaged in the practice of
pharmacist care and dispenses its prescriptions free of charge to appropriately screened and qualified indigent patients.

(8) "Collaborative pharmacy practice" is that practice of
pharmacist care where one or more pharmacists have jointly agreed,
on a voluntary basis, to work in conjunction with one or more
physicians under written protocol where the pharmacist or
pharmacists may perform certain patient care functions authorized
by the physician or physicians under certain specified conditions
and limitations.

(9) "Collaborative pharmacy practice agreement" is a written
and signed agreement,
which is a physician directed approach, that
is entered into between an individual physician or physician group,
an individual pharmacist or pharmacists and an individual patient
or the patient's authorized representative who has given informed
consent
that provides for collaborative pharmacy practice for the
purpose of drug therapy management of a patient, which has been
approved by the board, the Board of Medicine in the case of an
allopathic physician or the West Virginia Board of Osteopathic
Medicine in the case of an osteopathic physician.

(10) "Common Carrier" means any person or entity who
undertakes, whether directly or by any other arrangement, to
transport property including prescription drugs for compensation.

(11) "Component" means any active ingredient or added
substance intended for use in the compounding of a drug product,
including those that may not appear in such product.

(12) "Compounding" means:

(A) The preparation, mixing, assembling, packaging or labeling
of a drug or device:

(i) As the result of a practitioner's prescription drug order
or initiative based on the practitioner/patient/pharmacist
relationship in the course of professional practice for sale or
dispensing; or

(ii) For the purpose of, or as an incident to, research,
teaching or chemical analysis and not for sale or dispensing; and

(B) The preparation of drugs or devices in anticipation of
prescription drug orders based on routine, regularly observed
prescribing patterns.

(13) "Deliver" or "delivery" means the actual, constructive or
attempted transfer of a drug or device from one person to another,
whether or not for a consideration.

(14) "Device" means an instrument, apparatus, implement or
machine, contrivance, implant or other similar or related article,
including any component part or accessory, which is required under
federal law to bear the label, "Caution: Federal or state law
requires dispensing by or on the order of a physician."

(15) "Digital Signature" means an electronic signature based
upon cryptographic methods of originator authentication, and
computed by using a set of rules and a set of parameters so that
the identity of the signer and the integrity of the data can be
verified.

(16) "Dispense" or "dispensing" means the interpretation, evaluation, and implementation of a prescription drug order,
including the preparation, verification and delivery of a drug or
device to a patient or patient's agent in a suitable container
appropriately labeled for subsequent administration to, or use by,
a patient.

(17) "Distribute" or "Distribution" means to sell, offer to
sell, deliver, offer to deliver, broker, give away, or transfer a
drug, whether by passage of title, physical movement, or both. The
term does not include:

(A) To dispense or administer;

(B) (i) Delivering or offering to deliver a drug by a common
carrier in the usual course of business as a common carrier; or
providing a drug sample to a patient by a practitioner licensed to
prescribe such drug;

(ii) A health care professional acting at the direction and
under the supervision of a practitioner; or the pharmacy of a
hospital or of another health care entity that is acting at the
direction of such a practitioner and that received such sample in
accordance with the Prescription Drug Marketing Act and regulations
to administer or dispense;

(iii) Intracompany sales.

(18) "Drop shipment" means the sale of a prescription drug to
a wholesale distributor by the manufacturer of the prescription
drug or by that manufacturer's colicensed product partner, that
manufacturer's third party logistics provider, that manufacturer's exclusive distributor, or by an authorized distributor of record
that purchased the product directly from the manufacturer or from
one of these entities whereby:

(A) The wholesale distributor takes title to but not physical
possession of such prescription drug;

(B) The wholesale distributor invoices the pharmacy, pharmacy
warehouse, or other person authorized by law to dispense or
administer such drug; and

(C) The pharmacy, pharmacy warehouse or other person authorized
by law to dispense or administer such drug receives delivery of the
prescription drug directly from the manufacturer or from that
manufacturer's colicensed product partner, that manufacturer's third
party logistics provider, that manufacturer's exclusive distributor,
or from an authorized distributor of record that purchased the
product directly from the manufacturer or from one of these
entities.

(19) "Drug" means:

(A) Articles recognized as drugs by the United States Food and
Drug Administration, or in any official compendium, or supplement;

(B) An article, designated by the board, for use in the
diagnosis, cure, mitigation, treatment, or prevention of disease in
humans or other animals;

(C) Articles, other than food, intended to affect the structure
or any function of the body of human or other animals; and

(D) Articles intended for use as a component of any articles specified in paragraph (A), (B) or (C) of this subdivision.

(20) "Drug regimen review" includes, but is not limited to, the
following activities:

(A) Evaluation of the prescription drug orders and if
available, patient records for:

(i) Known allergies;

(ii) Rational therapy-contraindications;

(iii) Reasonable dose and route of administration; and

(iv) Reasonable directions for use.

(B) Evaluation of the prescription drug orders and patient
records for duplication of therapy.

(C) Evaluation of the prescription drug for interactions and/or
adverse effects which may include, but are not limited to, any of
the following:

(i) Drug-drug;

(ii) Drug-food;

(iii) Drug-disease; and

(iv) Adverse drug reactions.

(D) Evaluation of the prescription drug orders and if
available, patient records for proper use, including overuse and
underuse and optimum therapeutic outcomes.

(21) "Drug therapy management" means the review of drug therapy
regimens of patients by a pharmacist for the purpose of evaluating
and rendering advice to a physician regarding adjustment of the
regimen in accordance with the collaborative pharmacy practice agreement. Decisions involving drug therapy management shall be
made in the best interest of the patient. Drug therapy management
is limited to:

(A) Implementing, modifying and managing drug therapy according
to the terms of the collaborative pharmacy practice agreement;

(D) Ordering screening laboratory tests that are dose related
and specific to the patient's medication or are protocol driven and
are also specifically set out in the collaborative pharmacy practice
agreement between the pharmacist and physician.

(22) "Electronic data intermediary" means an entity that
provides the infrastructure to connect a computer system, hand-held
electronic device or other electronic device used by a prescribing
practitioner with a computer system or other electronic device used
by a pharmacy to facilitate the secure transmission of:

(A) An electronic prescription order;

(B) A refill authorization request;

(C) A communication; or

(D) Other patient care information.

(23) "E-prescribing" means the transmission, using electronic
media, of prescription or prescription-related information between
a practitioner, pharmacist, pharmacy benefit manager or health plan
as defined in 45 CFR §160.103, either directly or through an electronic data intermediary. E-prescribing includes, but is not
limited to, two-way transmissions between the point of care and the
pharmacist. E-prescribing may also be referenced by the terms
"electronic prescription" or "electronic order".

(24) "Electronic Signature" means an electronic sound, symbol,
or process attached to or logically associated with a record and
executed or adopted by a person with the intent to sign the record.

(25) "Electronic transmission" means transmission of
information in electronic form or the transmission of the exact
visual image of a document by way of electronic equipment.

(26) "Emergency medical reasons" include, but are not limited
to, transfers of a prescription drug by one pharmacy to another
pharmacy to alleviate a temporary shortage of a prescription drug;
sales to nearby emergency medical services, i.e., ambulance
companies and firefighting organizations in the same state or same
marketing or service area, or nearby licensed practitioners of
prescription drugs for use in the treatment of acutely ill or
injured persons; and provision of minimal emergency supplies of
prescription drugs to nearby nursing homes for use in emergencies
or during hours of the day when necessary prescription drugs cannot
be obtained.

(27) "Exclusive distributor" means an entity that:

(A) Contracts with a manufacturer to provide or coordinate
warehousing, wholesale distribution, or other services on behalf of
a manufacturer and who takes title to that manufacturer's prescription drug, but who does not have general responsibility to
direct the sale or disposition of the manufacturer's prescription
drug; and

(B) Is licensed as a wholesale distributor under this article.

(28) "FDA" means the Food and Drug Administration, a federal
agency within the United States Department of Health and Human
Services.

(29) "Health care entity" means a person that provides
diagnostic, medical, pharmacist care, surgical, dental treatment,
or rehabilitative care but does not include a wholesale distributor.

(30) "Health information" means any information, whether oral
or recorded in a form or medium, that:

(A) Is created or received by a health care provider, health
plan, public health authority, employer, life insurer, school or
university, or health care clearinghouse, and

(B) Relates to the past, present, or future physical or mental
health or condition of an individual; or the past, present, or
future payment for the provision of health care to an individual.

(31) "HIPAA" is the federal Health Insurance Portability and
Accountability Act of 1996 (Public Law 104-191).

(32) "Immediate container" means a container and does not
include package liners.

(33) "Individually identifiable health information" is
information that is a subset of health information, including
demographic information collected from an individual and is created or received by a health care provider, health plan, employer, or
health care clearinghouse; and relates to the past, present, or
future physical or mental health or condition of an individual; the
provision of health care to an individual; or the past, present, or
future payment for the provision of health care to an individual;
and that identifies the individual; or with respect to which there
is a reasonable basis to believe the information can be used to
identify the individual.

(34) "Intracompany sales" means any transaction between a
division, subsidiary, parent, and/or affiliated or related company
under the common ownership and control of a corporate or other legal
business entity.

(35) "Label" means a display of written, printed, or graphic
matter upon the immediate container of any drug or device.

(36) "Labeling" means the process of preparing and affixing a
label to a drug container exclusive, however, of a labeling by a
manufacturer, packer or distributor of a nonprescription drug or
commercially packaged prescription drug or device.

(38) "Mail-order pharmacy" means a pharmacy, regardless of its
location, which dispenses greater than twenty-five percent
prescription drugs via the mail or other delivery services.

(39) "Manufacturer" means any person who is engaged in manufacturing, preparing, propagating, processing, packaging,
repackaging or labeling of a prescription drug, whether within or
outside this state.

(40) "Manufacturing" means the production, preparation,
propagation or processing of a drug or device, either directly or
indirectly, by extraction from substances of natural origin or
independently by means of chemical or biological synthesis and
includes any packaging or repackaging of the substance or substances
or labeling or relabeling of its contents and the promotion and
marketing of the drugs or devices. Manufacturing also includes the
preparation and promotion of commercially available products from
bulk compounds for resale by pharmacies, practitioners or other
persons.

(41) "Medical order" means a lawful order of a practitioner
that may or may not include a prescription drug order.

(42) "Medication therapy management" is a distinct service or
group of services that optimize medication therapeutic outcomes for
individual patients. Medication therapy management services are
independent of, but can occur in conjunction with, the provision of
a medication or a medical device. Medication therapy management
encompasses a broad range of professional activities and
responsibilities within the licensed pharmacist's scope of practice.

These services may include the following, according to the
individual needs of the patient:

(G) Providing verbal education and training designed to enhance
patient understanding and appropriate use of his or her medications;

(H) Providing information, support services and resources
designed to enhance patient adherence with his or her medication
therapeutic regimens;

(I) Coordinating and integrating medication therapy management
services within the broader health care management services being
provided to the patient; and

(J) Such other patient care services as may be allowed by law.

(43) "Misbranded" means a drug or device that has a label that
is false or misleading in any particular; or the label does not bear
the name and address of the manufacturer, packer, or distributor and
does not have an accurate statement of the quantities of the active ingredients in the case of a drug; or the label does not show an
accurate monograph for prescription drugs.

(44) "Nonprescription drug" means a drug which may be sold
without a prescription and which is labeled for use by the consumer
in accordance with the requirements of the laws and rules of this
state and the federal government.

(45) "Normal distribution channel" means a chain of custody for
a prescription drug that goes directly or by drop shipment, from a
manufacturer of the prescription drug, the manufacturer's
third-party logistics provider, or the manufacturer's exclusive
distributor to:

(A) A wholesale distributor to a pharmacy to a patient or other
designated persons authorized by law to dispense or administer such
prescription drug to a patient;

(B) A wholesale distributor to a chain pharmacy warehouse to
that chain pharmacy warehouse's intracompany pharmacy to a patient
or other designated persons authorized by law to dispense or
administer such prescription drug to a patient;

(C) A chain pharmacy warehouse to that chain pharmacy
warehouse's intracompany pharmacy to a patient or other designated
persons authorized by law to dispense or administer such
prescription drug to a patient;

(D) A pharmacy or to other designated persons authorized by law
to dispense or administer such prescription drug to a patient; or

(E) As prescribed by the board's legislative rules.

(46) "Patient counseling" means the communication by the
pharmacist of information, as prescribed further in the rules of the
board, to the patient to improve therapy by aiding in the proper use
of drugs and devices.

(47) "Pedigree" means a statement or record in a written form
or electronic form, approved by the board, that records each
wholesale distribution of any given prescription drug (excluding
veterinary prescription drugs), which leaves the normal distribution
channel.

(48) "Person" means an individual, corporation, partnership,
association or any other legal entity, including government.

(49) "Pharmacist" means an individual currently licensed by
this state to engage in the practice of pharmacist care.

(50) "Pharmacist Care" means the provision by a pharmacist of
patient care activities, with or without the dispensing of drugs or
devices, intended to achieve outcomes related to the cure or
prevention of a disease, elimination or reduction of a patient's
symptoms, or arresting or slowing of a disease process and as
provided for in section ten.

(51) "Pharmacist-in-charge" means a pharmacist currently
licensed in this state who accepts responsibility for the operation
of a pharmacy in conformance with all laws and legislative rules
pertinent to the practice of pharmacist care and the distribution
of drugs and who is personally in full charge of the pharmacy and
pharmacy personnel.

(52) "Pharmacist's scope of practice pursuant to the
collaborative pharmacy practice agreement" means those duties and
limitations of duties placed upon the pharmacist by the
collaborating physician, as jointly approved by the board and the
Board of Medicine or the West Virginia Board of Osteopathic
Medicine.

(53) "Pharmacy" means any place within this state where drugs
are dispensed and pharmacist care is provided and any place outside
of this state where drugs are dispensed and pharmacist care is
provided to residents of this state.

(54) "Pharmacy Intern" or "Intern" means an individual who is
currently licensed to engage in the practice of pharmacist care
while under the supervision of a pharmacist.

(55) "Pharmacy related primary care" means the pharmacist's
activities in patient education, health promotion, selection and use
of over the counter drugs and appliances and referral or assistance
with the prevention and treatment of health related issues and
diseases.

(56) "Pharmacy Technician" means a person registered with the
board to practice certain tasks related to the practice of
pharmacist care as permitted by the board.

(57) "Physician" means an individual currently licensed, in
good standing and without restrictions, as an allopathic physician
by the West Virginia Board of Medicine or an osteopathic physician
by the West Virginia Board of Osteopathic Medicine.

(58) "Practice of telepharmacy" means the provision of
pharmacist care by properly licensed pharmacists located within
United States jurisdictions through the use of telecommunications
or other technologies to patients or their agents at a different
location that are located within United States jurisdictions.

(59) "Practitioner" means an individual authorized by a
jurisdiction of the United States to prescribe drugs in the course
of professional practices, as allowed by law.

(60) "Prescription drug" means any human drug required by
federal law or regulation to be dispensed only by prescription,
including finished dosage forms and active ingredients subject to
section 503(b) of the federal food, drug and cosmetic act.

(61) "Prescription or prescription drug order" means a lawful
order from a practitioner for a drug or device for a specific
patient, including orders derived from collaborative pharmacy
practice, where a valid patient-practitioner relationship exists,
that is communicated to a pharmacist in a pharmacy.

(62) "Product Labeling" means all labels and other written,
printed, or graphic matter upon any article or any of its containers
or wrappers, or accompanying such article.

(63) "Repackage" means changing the container, wrapper,
quantity, or product labeling of a drug or device to further the
distribution of the drug or device.

(64) "Repackager" means a person who repackages.

(65) "Therapeutic equivalence" mean drug products classified as therapeutically equivalent can be substituted with the full
expectation that the substituted product will produce the same
clinical effect and safety profile as the prescribed product which
contain the same active ingredient(s); dosage form and route of
administration; and strength.

(66) "Third-party logistics provider" means a person who
contracts with a prescription drug manufacturer to provide or
coordinate warehousing, distribution or other services on behalf of
a manufacturer, but does not take title to the prescription drug or
have general responsibility to direct the prescription drug's sale
or disposition. A third-party logistics provider shall be licensed
as a wholesale distributor under this article and, in order to be
considered part of the normal distribution channel, shall also be
an authorized distributor of record.

(67) "Valid patient-practitioner relationship" means the
following have been established:

(A) A patient has a medical complaint;

(B) A medical history has been taken;

(C) A face-to-face physical examination adequate to establish
the medical complaint has been performed by the prescribing
practitioner or in the instances of telemedicine through
telemedicine practice approved by the appropriate practitioner
board; and

(D) Some logical connection exists between the medical
complaint, the medical history, and the physical examination and the drug prescribed.

(68) "Wholesale distribution" and "wholesale distributions"
mean distribution of prescription drugs, including directly or
through the use of a third-party logistics provider or any other
situation in which title, ownership or control over the prescription
drug remains with one person or entity but the prescription drug is
brought into this state by another person or entity on his, her or
its behalf, to persons other than a consumer or patient, but does
not include:

(A) Intracompany sales, as defined in subdivision thirty-four
of this subsection;

(B) The purchase or other acquisition by a hospital or other
health care entity that is a member of a group purchasing
organization of a drug for its own use from the group purchasing
organization or from other hospitals or health care entities that
are members of such organizations;

(C) The sale, purchase or trade of a drug or an offer to sell,
purchase or trade a drug by a charitable organization described in
section 501(c)(3) of the United States Internal Revenue Code of 1986
to a nonprofit affiliate of the organization to the extent otherwise
permitted by law;

(D) The sale, purchase or trade of a drug or an offer to sell,
purchase or trade a drug among hospitals or other health care
entities that are under common control. For purposes of this
article, "common control" means the power to direct or cause the direction of the management and policies of a person or an
organization, whether by ownership of stock, voting rights, by
contract, or otherwise;

(E) The sale, purchase or trade of a drug or an offer to sell,
purchase or trade a drug for "emergency medical reasons" for
purposes of this article includes transfers of prescription drugs
by a retail pharmacy to another retail pharmacy to alleviate a
temporary shortage, except that the gross dollar value of such
transfers shall not exceed five percent of the total prescription
drug sales revenue of either the transferor or transferee pharmacy
during any twelve consecutive month period;

(F) The sale, purchase or trade of a drug, an offer to sell,
purchase, or trade a drug or the dispensing of a drug pursuant to
a prescription;

(G) The distribution of drug samples by manufacturers'
representatives or distributors' representatives, if the
distribution is permitted under federal law [21 U. S. C. 353(d)];

(H) Drug returns by a pharmacy or chain drug warehouse to
wholesale drug distributor or the drug's manufacturer; or

(J) The sale, purchase or trade of blood and blood components
intended for transfusion.

Note: WV Code updated with legislation passed through the 2015 Regular Session
The WV Code Online is an unofficial copy of the annotated WV Code, provided as a convenience. It has NOT been edited for publication, and is not in any way official or authoritative.